FDA — authorised 12 April 1956
- Marketing authorisation holder: PFIZER
- Status: approved
🇺🇸 Hydroxyzine Hydrochloride in United States
FDA authorised Hydroxyzine Hydrochloride on 12 April 1956
Marketing authorisations
FDA — authorised 18 September 1957
- Application: NDA011111
- Marketing authorisation holder: PFIZER
- Local brand name: VISTARIL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 August 1979
- Application: ANDA085551
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: HYDROXYZINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 June 1980
- Application: ANDA087014
- Marketing authorisation holder: ORGANON USA INC
- Local brand name: ORGATRAX
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 April 1981
- Application: ANDA087216
- Marketing authorisation holder: IVAX PHARMS
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 June 1981
- Application: ANDA087546
- Marketing authorisation holder: HOSPIRA
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 July 1981
- Application: ANDA087274
- Marketing authorisation holder: WATSON LABS
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 January 1982
- Application: ANDA087603
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 January 1982
- Application: ANDA087604
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 January 1982
- Application: ANDA087602
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 April 1982
- Application: ANDA087294
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 20 December 1982
- Application: ANDA087871
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 April 1983
- Application: ANDA087857
- Marketing authorisation holder: MUTUAL PHARM
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 April 1983
- Application: ANDA087860
- Marketing authorisation holder: MUTUAL PHARM
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 April 1983
- Application: ANDA087862
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 September 1983
- Application: ANDA088350
- Marketing authorisation holder: WATSON LABS
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 September 1983
- Application: ANDA088348
- Marketing authorisation holder: WATSON LABS
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 September 1983
- Application: ANDA088349
- Marketing authorisation holder: WATSON LABS
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 January 1986
- Application: ANDA088617
- Marketing authorisation holder: PLIVA
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 January 1986
- Application: ANDA088618
- Marketing authorisation holder: PLIVA
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 January 1986
- Application: ANDA088619
- Marketing authorisation holder: PLIVA
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 May 1986
- Application: ANDA089382
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 May 1986
- Application: ANDA089383
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 May 1986
- Application: ANDA089381
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 March 1994
- Application: ANDA081151
- Marketing authorisation holder: WATSON LABS
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 March 1994
- Application: ANDA081150
- Marketing authorisation holder: WATSON LABS
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 March 1994
- Application: ANDA081149
- Marketing authorisation holder: WATSON LABS
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 October 1994
- Application: ANDA040010
- Marketing authorisation holder: HIKMA
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 9 December 1994
- Application: ANDA086183
- Marketing authorisation holder: SANDOZ
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 25 September 1995
- Application: ANDA081054
- Marketing authorisation holder: PLIVA
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 August 1997
- Application: ANDA040156
- Marketing authorisation holder: IMPAX LABS INC
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 22 July 2004
- Application: ANDA040563
- Marketing authorisation holder: ABLE
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 July 2004
- Application: ANDA040559
- Marketing authorisation holder: ABLE
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 July 2004
- Application: ANDA040562
- Marketing authorisation holder: ABLE
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 December 2004
- Application: ANDA040604
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 May 2005
- Application: ANDA040580
- Marketing authorisation holder: PRINSTON INC
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 March 2008
- Application: ANDA040812
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 March 2008
- Application: ANDA040840
- Marketing authorisation holder: NORTHSTAR HLTHCARE
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 March 2008
- Application: ANDA040841
- Marketing authorisation holder: NORTHSTAR HLTHCARE
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 March 2008
- Application: ANDA040842
- Marketing authorisation holder: NORTHSTAR HLTHCARE
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 May 2008
- Application: ANDA040805
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 June 2008
- Application: ANDA040899
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 June 2008
- Application: ANDA040804
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 September 2008
- Application: ANDA040808
- Marketing authorisation holder: AMNEAL PHARM
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 June 2010
- Application: ANDA091176
- Marketing authorisation holder: RISING
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 August 2013
- Application: ANDA201674
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 8 November 2016
- Application: ANDA040786
- Marketing authorisation holder: KVK TECH
- Indication: Labeling
- Status: approved
FDA — authorised 29 March 2017
- Application: ANDA207121
- Marketing authorisation holder: NUVO PHARMS INC
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 April 2025
- Application: ANDA219289
- Marketing authorisation holder: BIONPHARMA
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 16 December 2025
- Application: ANDA219648
- Marketing authorisation holder: NOVITIUM PHARMA
- Status: approved
FDA
- Application: ANDA089396
- Marketing authorisation holder: HALSEY
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA087593
- Marketing authorisation holder: SOLOPAK
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA087591
- Marketing authorisation holder: SOLOPAK
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA087595
- Marketing authorisation holder: SOLOPAK
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA088862
- Marketing authorisation holder: PHARMAFAIR
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA087596
- Marketing authorisation holder: SOLOPAK
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA088551
- Marketing authorisation holder: QUANTUM PHARMICS
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088540
- Marketing authorisation holder: QUANTUM PHARMICS
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088529
- Marketing authorisation holder: QUANTUM PHARMICS
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA089366
- Marketing authorisation holder: HALSEY
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA087245
- Marketing authorisation holder: SANDOZ
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA087246
- Marketing authorisation holder: SANDOZ
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088881
- Marketing authorisation holder: PHARMAFAIR
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA087273
- Marketing authorisation holder: ALTANA
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA087592
- Marketing authorisation holder: SMITH AND NEPHEW
- Local brand name: HYDROXYZINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
Hydroxyzine Hydrochloride in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Hydroxyzine Hydrochloride approved in United States?
Yes. FDA authorised it on 12 April 1956; FDA authorised it on 18 September 1957; FDA authorised it on 24 August 1979.
Who is the marketing authorisation holder for Hydroxyzine Hydrochloride in United States?
PFIZER holds the US marketing authorisation.